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Trial record 65 of 82 for:    acne AND Acne Scars

Multi-Center, Clinical Evaluation of the Cutera Secret RF Device

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ClinicalTrials.gov Identifier: NCT03424161
Recruitment Status : Recruiting
First Posted : February 6, 2018
Last Update Posted : February 12, 2018
Sponsor:
Information provided by (Responsible Party):
Cutera Inc.

Brief Summary:
The objectives of this study are to evaluate the efficacy and safety of the Cutera Secret RF device.

Condition or disease Intervention/treatment Phase
Skin Quality Device: Secret RF Not Applicable

Detailed Description:
This is a multi-center, study in approximately 40 subjects, ages 18 to 65. Subjects may receive up to four treatments and will be followed at 4 and 12 weeks post the final treatment. A small subgroup of subjects may elect to have a biopsy of the treatment area prior to and after treatment. (Immediate, 72 Hours post initial treatment and 3 months post last treatment).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Multi-Center, Clinical Evaluation of the Cutera Secret RF Device
Actual Study Start Date : January 10, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : May 2019

Arm Intervention/treatment
Secret RF
Treatment with Secret RF for skin quality
Device: Secret RF
Subjects may receive up to 4 treatments




Primary Outcome Measures :
  1. Improvement in Skin Quality Assessment [ Time Frame: Changes from Baseline at 4 weeks follow-up, and at 12 weeks follow-up ]
    Efficacy of treatment(s) with Cutera Secret RF measuring the changes in skin quality from Baseline to the 4 week follow-up visit, and from Baseline to the 12 week follow-up visit, as assessed by the study investigator using Skin Quality Rating Scale (1-10) for Radiance(1=No Radiance/worst to 10=maximum radiance/best), Smoothness(1=Very Rough/worst to 10=Very Smooth/best), Pigmentation(Very Irregular pigmentation/worst to 10=Very Uniform pigmentation/best), Erythema(1=Intense redness/worst to 10=No redness/best), and Pore size(1=Very Large pores/worst to 10=Minimal pores/best).

  2. Improvement in Acne Scar Assessment, if present [ Time Frame: Changes from Baseline at 4 weeks follow-up, and at 12 weeks follow-up ]
    Efficacy of treatment(s) with Cutera Secret RF measuring the changes in acne scarring from Baseline to the 4 week follow-up visit, and from Baseline to the 12 week follow-up visit, as assessed by the study investigator using ASAS: Acne scar Severity Assessment Scale if scars are present (+1=clear/best, +2=very mild, +3=mild, +4=moderate, or +5=severe/worst)

  3. Improvement in Wrinkle Assessment [ Time Frame: Changes from Baseline at 4 weeks follow-up, and at 12 weeks follow-up ]
    Efficacy of treatment(s) with Cutera Secret RF measuring the changes in number and depth of wrinkles from Baseline to the 4 week follow-up visit, and from Baseline to the 12 week follow-up visit as assessed by the study investigator using FWCS: Fitzpatrick Wrinkle Classification System (1-3=fine wrinkles, 4-6=moderate depth of wrinkles & moderate number of lines, 7-9=severe depth of wrinkles & numerous lines)

  4. Overall Aesthetic Improvement [ Time Frame: at 4 weeks follow-up and 12 weeks follow-up ]
    Efficacy of treatment(s) with Cutera Secret RF measuring the global skin improvement at the 4 week follow-up visit, and at the 12 week follow-up visit as assessed by the study investigator using GAIS: Global Aesthetic Improvement Scale (+4=Very Significant Improvement (≥75%), +3=Significant Improvement (50-74%), +2=Moderate Improvement (25-49%), +1=Mild Improvement (5-24%), or 0=No Change (<5%))


Secondary Outcome Measures :
  1. Device Safety [ Time Frame: through study completion, an average of 1+1/2 years ]
    Safety of the Cutera Secret RF laser as measured by the frequency and severity (0=none, 1=mild, 2=moderate, or 3=severe) of device related adverse events.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subject must be able to read, understand and sign the Informed Consent Form.
  2. Female or Male, 18 to 65 years of age (inclusive).
  3. Willing to undergo treatments with Secret RF.
  4. Willing to have very limited sun exposure and use sunscreen on the treatment area every day for the duration of the study, including the follow-up period.
  5. Subject must adhere to the follow-up schedule and study instructions.
  6. Agree to not undergo any other cosmetic procedure(s) or treatment(s) on the treatment area during the study and has no intention of having such procedures performed during the course of the study.
  7. Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, (educational and/or marketing), publications, and any additional marketing purposes.
  8. For female subjects: not pregnant or lactating and is either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control prior to enrollment and during the entire course of the study.

Exclusion Criteria:

  1. Participation in a clinical trial of another device or drug within 1 month of study participation, or during the study period.
  2. History of clotting disorders and/or current use of blood thinning medications.
  3. History of autoimmune disorders or diabetes.
  4. Cardiac pacemaker or active implantable metal device in the treatment area.
  5. Allergies to metals i.e. gold.
  6. Has a history of squamous cell carcinoma or melanoma in the treatment area.
  7. Significant uncontrolled concurrent illness that in the opinion of the Investigator would make the subject unsuitable for inclusion.
  8. History of any disease or condition that could impair wound healing.
  9. History of keloid formation or abnormal/delayed wound healing.
  10. History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen.
  11. Use of topical agents one week prior to treatment that may cause facial sensitivity.
  12. Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including but not limited to, open lacerations or abrasions, hidradenitis, rash, infection , or dermatitis of the treatment area prior to treatment (duration of resolution as per the Investigator's discretion).
  13. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study or a condition that would compromise the subject's ability to comply with the study requirements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03424161


Contacts
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Contact: Michaela Bell 415-657-5722 mbell@cutera.com
Contact: Ginger Pocock 415-657-5702 gpocock@cutera.com

Locations
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United States, California
Cutera Research Center Recruiting
Brisbane, California, United States, 94005
Contact: Mischell San Juan    415-657-5544    msanjuan@cutera.com   
Principal Investigator: Stephen Ronan, MD         
Sub-Investigator: Mishell San Juan, NP         
Sponsors and Collaborators
Cutera Inc.
Investigators
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Principal Investigator: Stephen Ronan, MD Cutera Research Center

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Responsible Party: Cutera Inc.
ClinicalTrials.gov Identifier: NCT03424161     History of Changes
Other Study ID Numbers: C-18-SRF01
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No